1 Clinical Trials for Various Conditions
The pilot study has two objectives: 1) to assess the post-infusion viability of INTERCEPT RBC by measuring the 24 hour post-infusion recovery ("PTR24") and lifespan of autologous RBCs prepared with the INTERCEPT System for RBC after storage for 35 days under standard blood banking conditions using two different RBC labels; 51-chromium and biotin. The control will be conventional untreated RBCs stored for 35 days; and 2) comparison and contrast of PTR24 and lifespan results of the 51-chromium and biotin labeling methods of RBC stored for 35 days under standard blood banking conditions. The purpose of gathering these data is to obtain more meaningful survival data for stored conventional and INTERCEPT RBCs over the entire 120 d RBC lifespan (51-Cr labeled RBC permits a maximum 28 d assessment as a result of 51-Cr's variable, progressive elution from RBC and radioactive half-life).